Treprostinil - USA

On Nov 14, 2017, Court of appeal for the federal circuit in a non-precedential opinion affirmed the decision of paten trial & appellate board (PTAB) which found product by process patent of Treprostinil (Remodulin) invalid. In Mar 2017, PTAB found UTC’s U.S. Patent Number 8,497,393 invalid for lack of novelty and obviousness in IPR proceeding (IPR2016-00006) filed by SteadyMed.

PTAB in its decision on novelty held that US’393 patent claims are product by process claims and prior art “Phares” discloses every element of the claims. UTC argued that prior art compound and instant compound are different in terms of purity. However, PTAB held that compound was known and process claims do not add any significant structural or functional characteristics to the claims. Moreover, difference in impurity is because of other factors such as time, solvent used during process of preparation. Therefore, Treprostinil was disclosed in prior art & process steps do not confer novelty to the claims. Hence, claims lack novelty over prior art.

With respect to obviousness, PTAB held that it was obvious to modify “Moriarty” prior art which discloses steps a & b of US’393 patent in view of “Phares” which discloses step c.  Person skilled in that art would have motivated to do so with reasonable expectation of success because by adding ethanolamine to tresprostinil one would eliminate the unnecessary step of purification.